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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Accenture
McKesson
Colorcon
McKinsey
US Army
Argus Health
Merck
Covington

Generated: August 16, 2018

DrugPatentWatch Database Preview

Cysteamine bitartrate - Generic Drug Details

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What are the generic drug sources for cysteamine bitartrate and what is the scope of cysteamine bitartrate freedom to operate?

Cysteamine bitartrate is the generic ingredient in two branded drugs marketed by Horizon Pharma Usa and Mylan, and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cysteamine bitartrate has thirty-five patent family members in twenty-five countries.

There are six drug master file entries for cysteamine bitartrate. Three suppliers are listed for this compound.

Summary for cysteamine bitartrate
Pharmacology for cysteamine bitartrate
Synonyms for cysteamine bitartrate
(+/-)-Tartaric Acid
(Mercaptoethyl)ammonium hydrogen tartrate
2-aminoethanethiol 2,3-dihydroxysuccinate
2-aminoethanethiol dihydrogen 2,3-dihydroxybutanedioate
2-aminoethanethiol; 2,3-dihydroxybutanedioate
27761-19-9
AC1L4POT
AC1Q5BFD
AKOS024332936
BC245627
C4H6O6.C2H7NS
CHEBI:50386
CHEMBL2062263
CTK4G0224
EINECS 248-641-7
FT-0696891
LS-174194
MCULE-1129308393
Mercamine bitartrate
Mercaptoethylamine bitartrate
SCHEMBL49513

US Patents and Regulatory Information for cysteamine bitartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for cysteamine bitartrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,129,433 Enterically coated cysteamine, cystamine and derivatives thereof ➤ Sign Up
9,511,039 Enterically coated cysteamine, cystamine and derivatives thereof ➤ Sign Up
9,750,708 Enterically coated cysteamine, cystamine and derivatives thereof ➤ Sign Up
9,795,578 Enterically coated cysteamine, cystamine and derivatives thereof ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for cysteamine bitartrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00013 Denmark ➤ Sign Up PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906
0649 Netherlands ➤ Sign Up PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
/2014 Austria ➤ Sign Up PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
4 50001-2014 Slovakia ➤ Sign Up PRODUCT NAME: MERKAPTAMIN; FIRST REGISTRATION: EU/1/13/861, 20130906
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Cerilliant
Queensland Health
AstraZeneca
Medtronic
Chubb
Citi
US Department of Justice
Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.